Frequently Asked Questions

General FAQs

In addition to financial support, “supported” also means direct and indirect funding, other types of tangible support, such as providing lab or data management services, regulatory support, study drug supply for research activities. See the DAIDS glossary for definition of “DAIDS supported”.

Sites participating in studies where DAIDS is not the IND sponsor will be required to submit the same documents to the DAIDS Protocol Registration Office (PRO) as studies where DAIDS is the IND sponsor. The Protocol Registration algorithm defines the protocol registration requirements when DAIDS does not hold the IND, but provides funding. See the algorithm associated with the Protocol Registration Policy for additional details.

In general, it is recommended that if the networks/other groups have additional requirements for their studies, networks/other groups should develop guidance documents clearly stating the requirements sites must follow in addition to the DAIDS requirements.

If you need a submission expedited, please send an e-mail to the DAIDS PRO requesting an expedited review and the reason an expedited review is required. A determination will be made by DAIDS on a case by case basis.